title: The outcome of prostate cancer screening in a normal Japanese population with PSA of 2-4 ng/ml and the free/total PSA under 12%.
abstract: OBJECTIVE
  No previous study has reported the numbers of prostate cancer (PC) patients existing among a normal Japanese population with prostate-specific antigen (PSA) < 4 ng/ml. The aim of this study was to elucidate the performance of %free PSA as a screening tool for a normal Japanese population with PSA of 2-4 ng/ml and to examine the characteristics of cancer detected using this criterion.
  
  
  METHODS
  We conducted a prospective, multi-center study to evaluate the performance of %free PSA among a normal Japanese population. We decided on a %free PSA cutoff value of 12% according to the preliminary results. A total of 5548 consecutive screening volunteers aged 50-79 years were enrolled in the project. Men with total PSA > 4 ng/ml, or men with total PSA of 2-4 ng/ml and %free PSA of < or =12% were indicated to undergo 12 core biopsies.
  
  
  RESULTS
  There were 826 (14.9%) men with PSA of 2-4 ng/ml. Among them, those with %free PSA of < or =12% numbered 100 (12.1%). Forty-nine out of 100 men (49%) received biopsy, and 16 PC patients were detected. Among 10 patients undergoing radical prostatectomy, seven were associated with extra-prostatic extension (pT3) or high-grade cancer (Gleason score > or = 8).
  
  
  CONCLUSIONS
  We confirmed the ability of %free PSA and demonstrated that there are considerable numbers of PC patients among the normal Japanese population with PSA of 2-4 ng/ml. We ascertained that cancers detected in this study had a variety of tumor characteristics, including those of an aggressive nature.
authors.affiliation: Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan. ishidoya@uro.med.tohoku.ac.jp
authors.forename: Shigeto
authors.initials: S
authors.lastname: Ishidoya
authors.forename: Akihiro
authors.initials: A
authors.lastname: Ito
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Orikasa
authors.forename: Sadafumi
authors.initials: S
authors.lastname: Kawamura
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Tochigi
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kuwahara
authors.forename: Takuya
authors.initials: T
authors.lastname: Yamanobe
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.forename: Naoya
authors.initials: N
authors.lastname: Masumori
authors.forename: Taiji
authors.initials: T
authors.lastname: Tsukamoto
authors.forename: Daisuke
authors.initials: D
authors.lastname: Shibuya
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Arai
mesh_terms: D000368:Aged; D044466:Asian People / Q000706:statistics & numerical data*; D014408:Biomarkers, Tumor / Q000097:blood*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000453:epidemiology / Q000276:immunology* / Q000473:pathology; D012107:Research Design; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen